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Amici Ask Supreme Court to Review Sequenom Decision

Life Sciences Law & Industry Report connects the dots among the many disciplines that make up the burgeoning life sciences industry, with biweekly updates on current regulatory, legislative,...

April 25 — The Supreme Court should review an appeals court decision invalidating a breakthrough prenatal DNA testing patent, 22 life sciences companies, associations, scientists and law professors said in amicus briefs.

Sequenom Inc. petitioned the court on March 21 to grant certiorari (review) of the decision of the U.S. Court of Appeals for the Federal Circuit that Sequenom's patent involving the use of medical waste from the mother to determine whether there are fetal abnormalities is invalid as based on a natural phenomenon (10 LSLR 07, 4/1/16).

The method was considered a breakthrough because it was scientifically unexpected and a safer method and one less emotionally taxing for parents than the common practice of inserting a needle in the pregnant woman's abdomen.

The appeals court's decision caused such a widespread reaction through the life sciences community that at a session of the 2015 BIO International Convention, there were calls to either lobby Congress to rewrite the patent law to ensure that such discoveries are patent eligible or for the community to lean more toward trade secret protection for its discoveries and inventions and away from patents (9 LSLR 752, 6/26/15).

All of the 22 amicus (friends of the court) briefs asked the court to review Sequenom to clear up confusion it has caused and confusion created by Supreme Court decisions that inspired Sequenom and that invalidated patent claims derived from natural products and diagnostic methods, particularly Mayo Collaborative Servs. v. Prometheus Labs., Inc. (6 LSLR 404, 4/6/12).

The court's decision as to whether it will or won't grant certiorari is expected before the end of the session in June.

Restore Confidence in System

In their brief, Eli Lilly and Co., Eisai Inc., Upsher-Smith Laboratories Inc., Pfizer Inc. and Etiometry Inc. didn't specifically address the Sequenom claims. They instead wrote that the Supreme Court had expanded the exception to patentability that it created for claims directed to natural phenomenon, laws of nature and abstract ideas “such that today it applies to invalidate U.S. patents that would be clearly eligible for patenting under international norms.”

Calling the two-part test that the court established in Mayo“a surrogate for the broader policy question of whether a patent claim is so conceptual that rights under the patent might dominate or otherwise preempt access” to the judicial exception, the five amici said that, like many surrogate tests, the Mayo test risks overreaching its policy objectives.

“This risk is magnified when the implicit exception is applied as a ‘threshold test.' Not knowing if one or more of the remaining statutory patentability requirements would invalidate a patent claim, the tendency is to stretch the threshold test’s application to assure a potentially problematic claim is invalidated—lest such a claim might otherwise survive as valid under the explicit statutory requirements. Moreover, in applying such a non-statutory limitation as a threshold consideration, it inherently operates without considering whether or how the present, explicit statutory framework, taken as a whole, may operate to routinely invalidate conceptual patent claims,” the companies wrote.

Novartis AG wrote in its brief, “The interpretation of Mayo that the Federal Circuit felt compelled to cement in this case cannot really ever know any bounds, because it gives rise to a new eligibility standard that ensures that the judicial exceptions expand, and that the scope of eligible subject matter shrinks, as the field of art progresses.”

The company continued, “This case presents the right opportunity for this Court to retake the reins of subject matter eligibility law, to avert the ‘crisis of patent law and medical innovation' that Judge [Alan D.] Lourie lamented is upon us [in his opinion on the Federal Circuit's denying a full court hearing in Sequenom (9 LSLR 24, 12/11/15)] and to restore the confidence that so many have now lost in the system of incentives that controls the fate of so many critical areas of medicine.”

Court's Framework Overinclusive?

In their joint brief , the Biotechnology Innovation Organization, the Pharmaceutical Research and Manufacturers of America and the Association of University Technology Managers said that they are concerned that the development and commercialization of life-improving biotechnologies will be impeded and the U.S.'s premier status in the sector will be lost if this court doesn't address the mounting uncertainty of patent-eligible subject matter.

They added that numerous Federal Circuit judges wrote that the Sequenom invention “is precisely the type of meritorious invention that patents are designed to protect” and yet they “saw no basis under this Court’s recent decisions to evaluate the claims as a whole or sustain the patent’s validity.”

The three associations noted that the court had first addressed the patent eligibility of biotechnology patents under 35 U.S.C. §101 in Diamond v. Chakrabarty, 447 U.S. 303 (1980), and in the subsequent 30 years hadn't invalidated any patents under the patent-eligibility judicial exceptions.

But since 2010, they wrote, the scope of patent-eligible subject matter has become one of the most frequently debated and litigated topics of substantive patent law and a source of uncertainty for inventors, businesses, patent examiners and courts.

Prometheus Laboratories’ patent in Mayo was “a poor standard-bearer” for modeling important Supreme Court Section 101 precedent, the amici wrote, but in the wake of that and other court decisions, the Patent and Trademark Office and lower courts have interpreted the Mayo framework to encompass many situations in which the peculiar fact scenario of Mayo wasn't present.

“Amici urge this Court to grant Sequenom’s petition to consider whether the [Mayo ] framework has become over-inclusive in invalidating patents on meritorious inventions involving breakthrough biomedical discoveries that satisfy the terms of §101,” the five organizations wrote.

Should Be ‘Broad Archway.'

Ananda Mohan Chakrabarty, now a professor of microbiology and immunology at the University of Illinois at Chicago's College of Medicine whose patent was the subject of the court's 1980 decisions in Chakrabarty, wrote that the framework established in the court's recent decisions such as Mayo “has turned §101 into a needle’s eye that must be traversed, rather than the broad open archway it was intended to be. The proper role of the judicial exceptions to §101 should be de minimis, not primary, as they have become.”

Recent decisions have “turned §101 into a needle’s eye that must be traversed, ratherthan the broad open archway it was intended to be.”

In Sequenom, Chakrabarty wrote, the Federal Circuit erred in not determining from the beginning that the claimed subject matter of the patent fell within the “process” category of Section 101. But the bigger problem, he wrote, was that “the basic framework directed the court into the trees and the weeds of ‘inventive concept' and ‘conventional steps' [in the Mayo test] rather than viewing the forest from above.”

Chakrabarty wrote that the province of Section 101 “is simply whether the subject of the patent application is new and useful and made by mankind, recognizing that natural phenomena and laws of nature are not truly new and are not made by mankind,” citing the language of the Chakrabarty decision.

The “notions” of “inventive concept” and “conventional steps” are the province of 35 U.S.C. §§102-103 and 112, not of Section 101, he wrote.

“The Federal Circuit's decision was exceptionally disappointing to scientists,” Chakrabarty said. “This was because scientists knew that nobody had ever conceived of the possibility—much less shown any specific way—of using maternal blood, serum, or plasma to amplify selectively the paternally-inherited sequences in fetal DNA. Such an accomplishment embodies the very definition of ‘ingenuity’ that the framers of the U.S. Constitution urged the government and the nation to encourage.”

No Patent Law Support

Jeffrey Lefstin and Peter Menell, professors of law at the University of California, wrote in their brief that the Mayo court lacked adequate input on the fundamental question of whether applications of scientific discoveries are patent eligible.

“[T]he Nation’s patent statutes, stretching back to the founding era, unmistakably afford patent protection to technological innovations and scientific discoveries. The legislative record contains no hint of a second, ‘inventive application' hurdle for patent-eligibility of scientific discoveries. To the contrary, statutory text and legislative history reflect the transparent, sensible, and intuitive intention to encourage ‘inventors and discoverers' to reveal the ‘mysteries of nature,' whether or not they are inventively applied.”

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